Total Knee Arthroplasty: Functional and Clinical Outcomes

• Sponsor: Duke University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01811563
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Duration (Months): 36.8
• Patients Per Site Per Month: 1.6

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the differences in functional and patient reported outcomes between total knee replacement (TKA) implants. In addition, this work will examine the correlation between functional assessments and patient reported outcomes following surgery. All subjects will complete assessments preoperatively, 4-6 weeks following TKA and then one year following TKA. Subjects will complete a series of patient reported outcomes as well as a series of functional outcomes at each of the time points of interest. The analysis will include a repeated measures design to determine differences between groups across time as well as correlations between the functional and patient reported outcomes. This work will hopefully determine the importance of using objective functional outcomes following TKA as well as determining the need for patient assessments out to one year following surgery.

Condition or Disease	Intervention/Treatment	Phase
Knee Osteoarthritis	Device: Zimmer; Device: Stryker	N/A

Detailed Description

The number differences in subjects analyzed from baseline to 6 weeks to 52 weeks are due to the fact that we did not use the 6 week time point in the final analysis based on the clinical decision that 6 weeks was too early in recovery to provide accurate information for clinical decision making. Therefore the patients used in the final analysis were those subjects who were able to and completed the assessment at pre-op and 1 year post-op which is how we get to the 20 subjects per group.

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Clinical and Functional Outcomes Following Total Knee Replacement Using Two Different Implants
• Study Start Date: Feb 1, 2013
• Actual Primary Completion Date: Feb 26, 2016
• Actual Study Completion Date: Feb 26, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Stryker Subjects will be receiving the Stryker Triathlon total knee replacement	Device: Stryker
Active Comparator: Zimmer Subjects will be receiving a Zimmer NexGen total knee replacement	Device: Zimmer

Outcome Measures

Primary Outcome Measures

1. Change in Lower Quarter Y-Balance Test (YBT-LQ) (Dynamic Balance) From Baseline to 6 Weeks Following Total Knee Replacement [Baseline (Pre-Operative) to 6 weeks following total knee replacement]

   The lower quarter y-balance test (YBT-LQ) is a test of dynamic balance in unilateral stance that has been deemed to be reliable and valid. The YBT-LQ consists of each patient standing on one leg and reaching as far as they can with their non-stance leg in the anterior, posteromedial and posterolateral direction while standing on the other foot on a centralized stance platform. The composite score is calculated as the sum of the three reach directions divided by 3 time the limb length and will be reported as a percentage of limb length.

2. Change in Lower Quarter Y-Balance Test (YBT-LQ) (Dynamic Balance) From Baseline to 52 Weeks Following Total Knee Replacement [Baseline (Pre-Operative) to 52 weeks following total knee replacement]

   The lower quarter y-balance test (YBT-LQ) is a test of dynamic balance in unilateral stance that has been deemed to be reliable and valid. The YBT-LQ consists of each patient standing on one leg and reaching as far as they can with their non-stance leg in the anterior, posteromedial and posterolateral direction while standing on the other foot on a centralized stance platform. The composite score is calculated as the sum of the three reach directions divided by 3 time the limb length and will be reported as a percentage of limb length.

Secondary Outcome Measures

1. Change in Walking Speed From Baseline to 52 Weeks Following Total Knee Replacement. [Baseline and 52 weeks following total knee replacement]

   Each subject will complete three walking trials at a self-selected comfortable walking speed along a 5 meter walkway in order to record walking speed at each time point.

2. Walking Speed at 6 Weeks Following Total Knee Replacement. [6 weeks following total knee replacement]

   Each subject will complete three walking trials at a self-selected comfortable walking speed along a 5 meter walkway in order to record walking speed at each time point.

Other Outcome Measures

1. Change in University of California, Los Angeles (UCLA) Activity Score From Baseline to 52 Weeks Following Total Knee Replacement. [Baseline and 52 weeks following total knee replacement]

   The UCLA activity score is a validated patient reported outcome of overall physical activity. Results on a scale of 1 to 10, 1 is "Wholly Inactive, dependent on others, and can not leave residence" and 10 is "Regularly participates in impact sports".

2. University of California, Los Angeles (UCLA) Activity Score at 6 Weeks Following Total Knee Replacement. [6 weeks following total knee replacement]

   The UCLA activity score is a validated patient reported outcome of overall physical activity. Results on a scale of 1 to 10, 1 is "Wholly Inactive, dependent on others, and can not leave residence" and 10 is "Regularly participates in impact sports".

3. Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) Total From Baseline to 52 Weeks Following Total Knee Replacement. [Baseline (Pre-Operative) and 52 weeks following total knee replacement]

   The KOOS is a standardized and validated patient outcome score that assesses functional limitation in patient with knee problems. KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The previous week is the time period considered when answering the questions. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.

4. Change in Forgotten Joint Score (FJS) From 6 Weeks to 52 Weeks Following Total Knee Replacement. [6 weeks and 52 weeks following total knee replacement]

   The FJS is a patient reported measure of how bothersome the total joint replacement is for them, how much it affects daily activity and how much they are aware of the implant. The FJS is a 12-question survey regarding functional outcome, pain, stability, daily living, activity and sport. Scoring is from 0 to 4 with 0 as the best outcome; a low score means high satisfaction. Not all questions must be answered to score, all responses are summed and the total is divided by number of completed items multiplied by 25, with the final result subtracted from 100. The score range is from 0 to 100 with the highest score of 100 indicating the best outcome (the joint is completely "forgotten") and 0 indicating the worst outcome.

5. Knee Society Score (KSS) [Baseline (Pre-Operative), 6 weeks and 52 weeks following total knee replacement]

   The KSS is a patient reported measure of knee function that is specific to patients who are scheduled to receive or have previously had a total knee replacement. This outcome measures both patient reported pain and function changes from prior to surgery through recovery. The score range is from 0 to 100. The highest score of 100 points will be obtained by a well-aligned knee with no pain, 125 degrees of motion, and negligible anteroposterior and mediolateral instability.

6. Sit to Stand Time [Baseline (Pre-Operative), 6 weeks and 52 weeks following total knee replacement]

   The sit to stand test requires patients to stand up and sit down as many times as possible in 10 seconds from a standard arm chair.

7. Timed Get up and go [Baseline (Pre-Operative), 6 weeks and 52 weeks following total knee replacement]

   The timed up and go requires a patient to rise from a chair walk three meters around a piece of tape and return to the chair again as quickly as possible.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Patients requiring primary total knee replacement

2. Patients willing and able to comply with the follow-up visits and evaluations

3. Patients willing to sign informed consent approved by the Institutional Review Board

Exclusion Criteria:

1. Patients with inflammatory arthritis

2. Patients with diabetic neuropathy

3. Patients unable to ambulate without the use of an assistive device prior to surgery

4. Patients unable to stand in single limb stance on each foot prior to surgery.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Duke University Medical Center	Durham	North Carolina	United States	27710

Sponsors and Collaborators

• Duke University

Investigators

• Principal Investigator: Samuel S Wellman, MD, Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT01811563
• Other Study ID Numbers: Pro00043737; 193447
• First Posted: Mar 14, 2013
• Last Update Posted: Jun 2, 2017
• Last Verified: Apr 1, 2017

• Keywords provided by Duke University: Total Knee Replacement; Lower Quarter Y-Balance Test; Functional Outcomes; Patient Reported Outcomes
• Additional relevant MeSH terms: Osteoarthritis; Osteoarthritis, Knee

Study Results

Participant Flow

Recruitment Details	60 patients signed consent form but 12 were withdrawn at the time of surgery because they required a different implant not included in the study.

Arm/Group Title	Stryker	Zimmer
Arm/Group Description	Subjects will be receiving the Stryker Triathlon total knee replacement Stryker	Subjects will be receiving a Zimmer NexGen total knee replacement Zimmer
Period Title: Overall Study
STARTED	25	23
COMPLETED	20	20
NOT COMPLETED	5	3

Baseline Characteristics

Arm/Group Title	Stryker	Zimmer	Total
Arm/Group Description	Subjects will be receiving the Stryker Triathlon total knee replacement Stryker	Subjects will be receiving a Zimmer NexGen total knee replacement Zimmer	Total of all reporting groups
Overall Participants	25	23	48
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	61.9 (8.0)	63.1 (7.3)	62.5 (7.6)
Sex: Female, Male (Count of Participants)
Female	14 56%	10 43.5%	24 50%
Male	11 44%	13 56.5%	24 50%
Region of Enrollment (participants) [Number]
United States	25 100%	23 100%	48 100%

Outcome Measures

1. Primary Outcome

Title	Change in Lower Quarter Y-Balance Test (YBT-LQ) (Dynamic Balance) From Baseline to 6 Weeks Following Total Knee Replacement
Description	The lower quarter y-balance test (YBT-LQ) is a test of dynamic balance in unilateral stance that has been deemed to be reliable and valid. The YBT-LQ consists of each patient standing on one leg and reaching as far as they can with their non-stance leg in the anterior, posteromedial and posterolateral direction while standing on the other foot on a centralized stance platform. The composite score is calculated as the sum of the three reach directions divided by 3 time the limb length and will be reported as a percentage of limb length.
Time Frame	Baseline (Pre-Operative) to 6 weeks following total knee replacement

Outcome Measure Data

Analysis Population Description

Only subjects that were able to complete all of the YBT assessments at 6 weeks post total knee replacement were included in the analyses.

Arm/Group Title	Stryker	Zimmer
Arm/Group Description	Subjects will be receiving the Stryker Triathlon total knee replacement Stryker	Subjects will be receiving a Zimmer NexGen total knee replacement Zimmer
Measure Participants	21	22
YBT-LQ Composite Pre-Operative	69.98 (8.18)	67.52 (12.22)
YBT-LQ Composite 6 weeks	73.25 (7.95)	73.32 (9.15)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stryker, Zimmer
	Comments
	Type of Statistical Test	Equivalence
	Comments	Main effect for implant independent of time
Statistical Test of Hypothesis	p-Value	0.661
	Comments
	Method	ANOVA
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Stryker, Zimmer
	Comments
	Type of Statistical Test	Equivalence
	Comments	Main effect for time independent of implant
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANOVA
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Stryker, Zimmer
	Comments
	Type of Statistical Test	Equivalence
	Comments	Interaction between implant and time
Statistical Test of Hypothesis	p-Value	0.270
	Comments
	Method	ANOVA
	Comments

2. Primary Outcome

Title	Change in Lower Quarter Y-Balance Test (YBT-LQ) (Dynamic Balance) From Baseline to 52 Weeks Following Total Knee Replacement
Description	The lower quarter y-balance test (YBT-LQ) is a test of dynamic balance in unilateral stance that has been deemed to be reliable and valid. The YBT-LQ consists of each patient standing on one leg and reaching as far as they can with their non-stance leg in the anterior, posteromedial and posterolateral direction while standing on the other foot on a centralized stance platform. The composite score is calculated as the sum of the three reach directions divided by 3 time the limb length and will be reported as a percentage of limb length.
Time Frame	Baseline (Pre-Operative) to 52 weeks following total knee replacement

Outcome Measure Data

Analysis Population Description

Subjects used in the final analysis were those subjects who completed the assessment at pre-op and 1 year post-op (20 subjects per arm).

Arm/Group Title	Stryker	Zimmer
Arm/Group Description	Subjects will be receiving the Stryker Triathlon total knee replacement Stryker	Subjects will be receiving a Zimmer NexGen total knee replacement Zimmer
Measure Participants	20	20
YBT-LQ Composite Pre-Operative	79.45 (10.46)	79.24 (7.89)
YBT-LQ Composite Post-Op 52 Weeks	70.44 (9.31)	69.42 (13.39)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stryker, Zimmer
	Comments
	Type of Statistical Test	Equivalence
	Comments	Main effect for implant independent of time
Statistical Test of Hypothesis	p-Value	0.856
	Comments
	Method	ANOVA
	Comments	Main effect for implant, LQ-YBT Baseline to 52 weeks

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Stryker, Zimmer
	Comments
	Type of Statistical Test	Equivalence
	Comments	Time independent of implant, Baseline to 52 Weeks
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANOVA
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Stryker, Zimmer
	Comments
	Type of Statistical Test	Equivalence
	Comments	Implant by Time interaction, Baseline to 52 Weeks between Zimmer and Stryker
Statistical Test of Hypothesis	p-Value	0.822
	Comments
	Method	ANOVA
	Comments

3. Secondary Outcome

Title	Change in Walking Speed From Baseline to 52 Weeks Following Total Knee Replacement.
Description	Each subject will complete three walking trials at a self-selected comfortable walking speed along a 5 meter walkway in order to record walking speed at each time point.
Time Frame	Baseline and 52 weeks following total knee replacement

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stryker	Zimmer
Arm/Group Description	Subjects will be receiving the Stryker Triathlon total knee replacement Stryker	Subjects will be receiving a Zimmer NexGen total knee replacement Zimmer
Measure Participants	20	20
Walking Speed Pre-Operative	1.22 (0.21)	1.16 (0.28)
Walking Speed Post-Op 52 Weeks	1.41 (0.23)	1.28 (0.23)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stryker, Zimmer
	Comments
	Type of Statistical Test	Equivalence
	Comments	Main effect for implant, Baseline to 52 weeks
Statistical Test of Hypothesis	p-Value	.158
	Comments
	Method	ANOVA
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Stryker, Zimmer
	Comments
	Type of Statistical Test	Equivalence
	Comments	Main effect for time, Baseline to 52 weeks
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANOVA
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Stryker, Zimmer
	Comments
	Type of Statistical Test	Equivalence
	Comments	Interaction of time by implant, Baseline to 52 weeks
Statistical Test of Hypothesis	p-Value	0.365
	Comments
	Method	ANOVA
	Comments

4. Secondary Outcome

Title	Walking Speed at 6 Weeks Following Total Knee Replacement.
Description	Each subject will complete three walking trials at a self-selected comfortable walking speed along a 5 meter walkway in order to record walking speed at each time point.
Time Frame	6 weeks following total knee replacement

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stryker	Zimmer
Arm/Group Description	Subjects will be receiving the Stryker Triathlon total knee replacement Stryker	Subjects will be receiving a Zimmer NexGen total knee replacement Zimmer
Measure Participants	25	23
Mean (Standard Deviation) [miles per hour]	1.21 (0.28)	1.19 (0.22)

5. Other Pre-specified Outcome

Title	Change in University of California, Los Angeles (UCLA) Activity Score From Baseline to 52 Weeks Following Total Knee Replacement.
Description	The UCLA activity score is a validated patient reported outcome of overall physical activity. Results on a scale of 1 to 10, 1 is "Wholly Inactive, dependent on others, and can not leave residence" and 10 is "Regularly participates in impact sports".
Time Frame	Baseline and 52 weeks following total knee replacement

Outcome Measure Data

Analysis Population Description

Subjects used in the final analysis were those subjects who completed the assessment at pre-op and 1 year post-op (20 subjects per arm).

Arm/Group Title	Stryker	Zimmer
Arm/Group Description	Subjects will be receiving the Stryker Triathlon total knee replacement Stryker	Subjects will be receiving a Zimmer NexGen total knee replacement Zimmer
Measure Participants	20	20
UCLA Activity Pre-Operative	4.19 (1.33)	3.83 (1.38)
UCLA Activity Post-Op 52 Weeks	5.90 (1.55)	5.61 (1.91)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stryker, Zimmer
	Comments
	Type of Statistical Test	Equivalence
	Comments	Main effect for implant, baseline to 52 weeks
Statistical Test of Hypothesis	p-Value	.416
	Comments
	Method	ANOVA
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Stryker, Zimmer
	Comments
	Type of Statistical Test	Equivalence
	Comments	Main effect for time, Baseline to 52 weeks
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANOVA
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Stryker, Zimmer
	Comments
	Type of Statistical Test	Equivalence
	Comments	Implant by time interaction, baseline to 52 weeks
Statistical Test of Hypothesis	p-Value	0.917
	Comments
	Method	ANOVA
	Comments

6. Other Pre-specified Outcome

Title	University of California, Los Angeles (UCLA) Activity Score at 6 Weeks Following Total Knee Replacement.
Description	The UCLA activity score is a validated patient reported outcome of overall physical activity. Results on a scale of 1 to 10, 1 is "Wholly Inactive, dependent on others, and can not leave residence" and 10 is "Regularly participates in impact sports".
Time Frame	6 weeks following total knee replacement

Outcome Measure Data

Analysis Population Description

Only subjects who were able to complete the UCLA at six weeks were included in the analysis.

Arm/Group Title	Stryker	Zimmer
Arm/Group Description	Subjects will be receiving the Stryker Triathlon total knee replacement Stryker	Subjects will be receiving a Zimmer NexGen total knee replacement Zimmer
Measure Participants	25	22
Mean (Standard Deviation) [units on a scale]	4.48 (1.42)	4.73 (1.52)

7. Other Pre-specified Outcome

Title	Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) Total From Baseline to 52 Weeks Following Total Knee Replacement.
Description	The KOOS is a standardized and validated patient outcome score that assesses functional limitation in patient with knee problems. KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The previous week is the time period considered when answering the questions. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
Time Frame	Baseline (Pre-Operative) and 52 weeks following total knee replacement

Outcome Measure Data

Analysis Population Description

Subjects used in the final analysis were those subjects who completed the assessment at pre-op and 1 year post-op (20 subjects per arm).

Arm/Group Title	Stryker	Zimmer
Arm/Group Description	Subjects will be receiving the Stryker Triathlon total knee replacement Stryker	Subjects will be receiving a Zimmer NexGen total knee replacement Zimmer
Measure Participants	20	20
KOOS Total, Baseline Pre-Operative	45.60 (12.32)	46.08 (13.50)
KOOS Total, Post-Op 52 week	67.32 (35.62)	64.24 (38.79)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stryker, Zimmer
	Comments
	Type of Statistical Test	Equivalence
	Comments	Main effect by implant, Baseline to 52 weeks
Statistical Test of Hypothesis	p-Value	0.830
	Comments
	Method	ANOVA
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Stryker, Zimmer
	Comments
	Type of Statistical Test	Equivalence
	Comments	Main effect by time, baseline to 52 weeks
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANOVA
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Stryker, Zimmer
	Comments
	Type of Statistical Test	Equivalence
	Comments	Interaction between implant and time, baseline to 52 weeks
Statistical Test of Hypothesis	p-Value	0.728
	Comments
	Method	ANOVA
	Comments

8. Other Pre-specified Outcome

Title	Change in Forgotten Joint Score (FJS) From 6 Weeks to 52 Weeks Following Total Knee Replacement.
Description	The FJS is a patient reported measure of how bothersome the total joint replacement is for them, how much it affects daily activity and how much they are aware of the implant. The FJS is a 12-question survey regarding functional outcome, pain, stability, daily living, activity and sport. Scoring is from 0 to 4 with 0 as the best outcome; a low score means high satisfaction. Not all questions must be answered to score, all responses are summed and the total is divided by number of completed items multiplied by 25, with the final result subtracted from 100. The score range is from 0 to 100 with the highest score of 100 indicating the best outcome (the joint is completely "forgotten") and 0 indicating the worst outcome.
Time Frame	6 weeks and 52 weeks following total knee replacement

Outcome Measure Data

Analysis Population Description

Participants who completed the Forgotten Joint Score (FJS) at week 6 and week 52. Not all subjects completed the FJS.

Arm/Group Title	Stryker	Zimmer
Arm/Group Description	Subjects will be receiving the Stryker Triathlon total knee replacement Stryker	Subjects will be receiving a Zimmer NexGen total knee replacement Zimmer
Measure Participants	20	20
FJS, at 6 weeks	69.63 (20.9)	76.59 (20.39)
FJS, at 52 weeks	37.7 (21.4)	30.8 (29.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stryker, Zimmer
	Comments
	Type of Statistical Test	Equivalence
	Comments	Between implants at 6 weeks
Statistical Test of Hypothesis	p-Value	0.319
	Comments
	Method	t-test, 2 sided
	Comments

9. Other Pre-specified Outcome

Title	Knee Society Score (KSS)
Description	The KSS is a patient reported measure of knee function that is specific to patients who are scheduled to receive or have previously had a total knee replacement. This outcome measures both patient reported pain and function changes from prior to surgery through recovery. The score range is from 0 to 100. The highest score of 100 points will be obtained by a well-aligned knee with no pain, 125 degrees of motion, and negligible anteroposterior and mediolateral instability.
Time Frame	Baseline (Pre-Operative), 6 weeks and 52 weeks following total knee replacement

Outcome Measure Data

Analysis Population Description

Only 20 subjects in each arm completed the assessment at 1 year post-op.

Arm/Group Title	Stryker	Zimmer
Arm/Group Description	Subjects will be receiving the Stryker Triathlon total knee replacement Stryker	Subjects will be receiving a Zimmer NexGen total knee replacement Zimmer
Measure Participants	25	23
KSS Satisfaction, Baseline Pre-Operatively	11.1 (5.2)	13.6 (8.8)
KSS Satsifaction, 6 weeks	28.9 (7.3)	29.5 (8.8)
KSS Functional Activity, Baseline	44.3 (11.2)	47.0 (13.7)
KSS Functional Activity, 6 weeks	60.8 (18.1)	61.6 (16.7)
KSS Functional Activity, 52 weeks Post-operative	67.3 (35.6)	64.2 (38.8)

10. Other Pre-specified Outcome

Title	Sit to Stand Time
Description	The sit to stand test requires patients to stand up and sit down as many times as possible in 10 seconds from a standard arm chair.
Time Frame	Baseline (Pre-Operative), 6 weeks and 52 weeks following total knee replacement

Outcome Measure Data

Analysis Population Description

The 6 week time point was not used in the final analysis based on the clinical decision that 6 weeks was too early in recovery to provide accurate information for clinical decision making. Subjects used in the final analysis were those subjects who completed the assessment at pre-op and 1 year post-op (20 subjects per arm).

Arm/Group Title	Stryker	Zimmer
Arm/Group Description	Subjects will be receiving the Stryker Triathlon total knee replacement Stryker	Subjects will be receiving a Zimmer NexGen total knee replacement Zimmer
Measure Participants	25	23
Sit to stand Pre-Operative	3.90 (0.95)	4.34 (1.34)
Sit to stand Post-Op 6 weeks	4.5 (1.7)	4.6 (1.1)
Sit to stand Post-Op 52 weeks	5.40 (1.45)	5.47 (1.81)

11. Other Pre-specified Outcome

Title	Timed Get up and go
Description	The timed up and go requires a patient to rise from a chair walk three meters around a piece of tape and return to the chair again as quickly as possible.
Time Frame	Baseline (Pre-Operative), 6 weeks and 52 weeks following total knee replacement

Outcome Measure Data

Analysis Population Description

The 6 week time point was not used in the final analysis based on the clinical decision that 6 weeks was too early in recovery to provide accurate information for clinical decision making. Subjects used in the final analysis were those subjects who completed the assessment at pre-op and 1 year post-op (20 subjects per arm).

Arm/Group Title	Stryker	Zimmer
Arm/Group Description	Subjects will be receiving the Stryker Triathlon total knee replacement Stryker	Subjects will be receiving a Zimmer NexGen total knee replacement Zimmer
Measure Participants	24	23
Timed up and go Pre-Operative	9.55 (3.86)	9.07 (2.48)
Timed up and go Post-Op 6 weeks	9.38 (3.58)	8.89 (1.89)
Timed up and go Post-Op 52 weeks	6.99 (1.8)	7.17 (1.39)

Adverse Events

Time Frame	52 weeks
Arm/Group Title	Stryker		Zimmer
Arm/Group Description	Subjects will be receiving the Stryker Triathlon total knee replacement Stryker		Subjects will be receiving a Zimmer NexGen total knee replacement Zimmer
All Cause Mortality
	Stryker		Zimmer
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/23 (0%)
Serious Adverse Events
	Stryker		Zimmer
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/23 (0%)
Other (Not Including Serious) Adverse Events
	Stryker		Zimmer
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/25 (4%)		0/23 (0%)
Musculoskeletal and connective tissue disorders
Patient fell while completeing the 6 weeks testing	1/25 (4%)	1	0/23 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.